Catalog Number

350310

Brand Name

Ho Band

Version/Model Number

350310

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DZN

Product Code Name

INSTRUMENTS, DENTAL HAND

Public Device Record Key

98d87407-5959-4dad-a177-223bb25470d2

Public Version Date

October 05, 2022

Public Version Number

5

DI Record Publish Date

December 08, 2020

Package DI Number

20789594000941

Quantity per Package

12

Contains DI Package

10789594000944

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case